We have carried out a phase II study in advanced or metastatic transitional cell carcinoma of the bladder. Eligible patients had unresectable bladder cancer, previously treated with one line of systemic chemotherapy. Treatment consisted of ifosfamide 1000 mg/sm in a 2-hour infusion for 5 consecutive days from d.1 to d.5. Mesna was administered intravenously at a 20% of the ifosfamide dosage before ifosfamide and orally at 40% after 4 and 8 hours from the ifosfamide infusion. Twenty patients entered the study and received a total of 62 cycles: the treatment resulted feasible on an outpatient basis, with mild toxicity. Only one partial response was observed. With this dose and schedule, ifosfamide appeared less effective than in a previous report at higher doses. Toxicity was acceptable.

There is no clear cut eGFR above which PEM may be used without potential risks of renal toxicity. If PEM has to be used, all the coexisting risk factors for AKI should be possibly corrected.

A total of 32 patients with advanced non-small-cell lung cancer were treated with carboplatin (350 mg/m2, day 1) and vinorelbine (days 1 and 8) every 28 days. A response rate of 28% (95% confidence limits 12.5 - 43.7%) was observed. The activity of this combination was demonstrated in an outpatient setting with acceptable toxicity.

Summary We have evaluated the feasibility of an increase in dose intensity of the cisplatin, epidoxorubicin and cyclophosphamide (PEC) regimen, with granulocyte colony-stimulating factor (G-CSF) support, in 22 patients with advanced ovarian cancer. Twenty-one patients (95.4%) received six cycles of treatment: of these, 13 (61.9%) were also able to repeat cycles every 14 days as planned. Marrow toxicity was similar to that observed during conventional treatments. No severe mucositis or thrombocytopenia was observed. A clinical complete response was observed in 9 out of 16 evaluable patients (56.2%).Keywords: ovarian cancer; polychemotherapy; dose intensityThe importance of dose intensity in chemotherapy, i.e. the amount of drug delivered per unit of time, has been stressed in several experimental and clinical contributions after early retrospective analyses by Hryniuk and Bush (1984) and Hryniuk (1987) underlined the relationship between planned dose intensity and response rate in breast cancer. Based on another retrospective study (Levine and Hryniuk, 1987), ovarian cancer appears to be a particularly suitable model for intensification of chemotherapy: however, prospective data about the use of intensified regimens in this disease are still scarce.In the present study we have evaluated the feasibility of an increase of the dose intensity of a polychemotherapy regimen commonly used in ovarian cancer (PEC; cisplatin, epidoxorubicin and cyclophosphamide) . Such increase was obtained reducing the intervals between cycles, with the use of granulocyte colony-stimulating factor (filgrastim, G-CSF) as prophylactic supportive treatment. Patients and methodsTo be eligible for the trial, patients had to have histological diagnosis of epithelial ovarian carcinoma; previous adequate cytoreductive surgery was required, with FIGO III -IV staging; serum creatinine, serum bilirubin and haemogram had to be within normal limits. Informed consent was obtained from all patients.Chemotherapy consisted of cisplatin 50 mg m-2, epidoxorubicin 60 mg m-2 and cyclophosphamide 600 mg m-2, all administered intravenously on day 1 every 14 days for six cycles. Filgrastim was administered subcutaneously from day 4 to day 9 between cycles.In the case of incomplete marrow recovery (WBC < 3000 mm-' and/or platelets < 100.000 mm-3) on day 1 of the cycle, chemotherapy was delayed for 1 week or until complete marrow recovery. In the case of haemoglobin levels of 9 g dl-' or less a blood transfusion was supplied and chemotherapy was not postponed. In the case of a platelet count of 50 000 mm-3 or less, detected at any time during therapy, a 50% reduction of the doses of all drugs was planned for the remaining courses.The primary aim of the study was to evaluate the feasibility of accelerated PEC treatment: the activity of the treatment was also assessed according to WHO response criteria. Toxicity was evaluated according to ECOG criteria.Planned and total delivered dose intensity were calculated as the amount of drug (mg m-2) administered per unit of...

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